Kornimate/medical-research-clean huggingface dataset:
safety study of ragweed-spire in subjects with ragweed allergies and asthma

Conditions: Seasonal Allergic Rhinitis; Asthma

Summary: the purpose of this study is to determine whether it is safe to administer ragweed-spire to subjects suffering from both ragweed allergy and asthma.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years. * asthma treated by inhaled saba or inhaled saba plus low-medium dose ics in 6 weeks prior to randomisation. * a reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons. * positive skin prick test to ragweed * ragweed-specific immunoglobulin e (ige) ≥ 0.35 ku/l. exclusion criteria: * history of life-threatening asthma. * uncontrolled asthma according to gina * fev1 of \< 70 % of predicted, regardless of the cause. * administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). * history of severe drug allergy or anaphylactic reaction to food. * a history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)

Keywords: ragweed allergy rhinoconjunctivitis rhinitis asthma
effects of linagliptin on active glp-1 concentrations in subjects with renal impairment

Conditions: Diabetes Mellitus

Summary: this is a bi-centric, prospective, open study comparing the effects of linagliptin on active glp-1 concentrations in subjects with renal impairment compared to subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus based on the disease diagnostic criteria (who) classification exclusion criteria: * subjects with type 1 diabetes, maturity onset diabetes of the young (mody) or secondary forms of diabetes such as due to pancreatitis.
evaluation of the colonoscope with vision to 330 ° (full spectrum endoscopy) in the detection of colorectal adenomas

Conditions: Colorectal Adenoma

Summary: the coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. however the literature reports that the rate of omitted adenoma is still high (24 to 41%). the development of the fuse system (endochoice, usa) allows a larger field of view with a projection onto 3 screens (330° vision). a pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. this first study in france concerning this technology has the objectives to demonstrate the feasibility in france, the safety and to compare the rate of detected adenomas with data of the literature.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnostic colonoscopy exclusion criteria: * colorectal cancer * colic surgery * preparation of average or poor quality * rectal polyp of hyperplastic type \<2 mm
effects of a glp-1 receptor agonist on functional activation and connectivity of the brain

Conditions: Diabetes Mellitus

Summary: the aims this study is to explore the effect of a glp-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes

fifteen lean \[bmi(body mass index) less than 23 kg/m2\] type 2 diabetes subjects and fifteen obese (bmi more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, su(sulfonylurea), dpp4-inhibitors(dipeptidyl peptidase-4 inhibitor) will be recruited. every subject will be studied on 2 separate days in random order with 1-2 week intervals. these participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. neuroimaging composed with resting-12-min, visual stimulation task-12-min, t1-5-min, and diffusion tensor image-12-min will be proceeded. ad lib buffet will be provided to every participant and the intake will be measured. surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.

Eligibility criteria:
inclusion criteria: * bmi ≤ 23kg/m2 or bmi ≥ 26kg/m2 * participants with diabetes treated by diet or oral antidiabetic drug, hba1c less than 8.5% exclusion criteria: * those who diagnosed by type 1 diabetes * history of insulin therapy * aspartate aminotransferase(ast) or alanine transaminase(alt) \>2.5 times of upper normal reference range * estimated glomerular filtration rate(egfr) \<30 ml/min/1.73m2 * those who can't be performed mri

Keywords: lean/obese diabetes mellitus functional mri glp-1 appetite activation of brain connectivity
accuracy of intra ocular lens carlevale calculation

Conditions: Lens Diseases

Summary: the purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new carlevale sutureless scleral fixation posterior chamber intra ocular lens.

retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between october 2019 and avril 2022 in the ophthalmology department of poitiers hospital and la rochelle hospital.

Eligibility criteria:
inclusion criteria: * all patients who underwent implantation of carlevale between octobre 2019 and avril 2022 in the ophtalmologie department of poitiers hospital and la rochelle hospital exclusion criteria: * post surgery best corrected visual acuity worse than 20/40 * keratoconus * macular oedema
inclisiran for participants with atherosclerotic cardiovascular disease and elevated low-density lipoprotein cholesterol

Conditions: ASCVD; Elevated Cholesterol

Summary: this is a phase iii, placebo-controlled, double-blind, randomized study in participants with ascvd and elevated ldl-c despite maximum tolerated dose of ldl-c lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (sc) inclisiran injection(s). the study will be a multicenter study in the united states.


Eligibility criteria:
inclusion criteria: 1. male or female participants ≥18 years of age. 2. history of ascvd (coronary heart disease \[chd\], cardiovascular disease \[cvd\], or peripheral arterial disease \[pad\]). 3. serum ldl-c ≥1.8 millimole (mmol)/liter (l) (≥70 mg/dl). 4. fasting triglyceride \<4.52 mmol/l (\<400 mg/dl) at screening. 5. participants on statins should be receiving a maximally tolerated dose. 6. participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins. 7. subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation. exclusion criteria: 1. new york heart association (nyha) class iv heart failure. 2. uncontrolled cardiac arrhythmia 3. uncontrolled severe hypertension 4. active liver disease 5. females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (for example, combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. exemptions from this criterion: 1. women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. 2. postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. 3. women who are surgically sterilized at least 3 months prior to enrollment. 6. males who are unwilling to use an acceptable method of birth control during the entire study period (such as condom with spermicide). 7. treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer. 8. treatment (within 90 days of screening) with monoclonal antibodies directed towards pcsk9 the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: inclisiran sodium ascvd ldl-c
night time use of thiazide diuretics for improved reduction in stone risk in stone formers with elevated urine calcium

Conditions: Kidney Stones

Summary: thiazide diuretics will be more effective in lowering urine calcium excretion if taken at night as compared to the daytime. it will therefore be more effective in reducing kidney stone recurrence in nephrolithiasis patients with elevated urine calcium who are known to have increased risk of kidney stones at night time.

the study will be divided into three phases for every single patient, investigators will study 15-20 stone formers who have previously documented elevated urine calcium excretion, with a plan to measure their urine chemistries at baseline (if they currently use thiazide diuretics, they will come off of their respective thiazide for a 7-day washout period). investigators will ask them to collect urine samples in two 12-hour intervals: on awakening, the 1st sample starts to before supper; 2nd sample begins after dinner and extends overnight with fasting after dinner, these measurements will be used as controls. then patients will be started back on diuretics (25mg of chlorthalidone for the primary study; pending the results this may be repeated with 25mg of hydrochlorothiazide as a second substudy) which they will take in the daytime; after a 6-day acclimation period, two 12-hour urine samples will be collected as in the washout period. for the third study period, the patients will then begin taking the thiazide after dinner. after a 6-day acclimation period, the third set of urine collections will be done.

Eligibility criteria:
inclusion criteria: * patients with recurrent calcium kidney stones (at least 2 episodes) and either a higher urine calcium excretion (urine ca \>200 mg/d or \> 4 mg/kg body weight) or, * in patients who currently take a thiazide diuretic, a history of elevated urine calcium prior to medication use; * also capable of signing consent and doing 24-hour urine collections repeatedly. exclusion criteria: * patients with primary hyperparathyroidism, renal tubular acidosis, chronic kidney disease (serum creatinine \> 1.5 mg/dl), inflammatory bowel disease, gout, * patients taking thiazides with a history of hypertension, * patients with baseline systolic blood pressure less than 110mmhg

Keywords: nephrolithiasis calcium stones kidney stones hypercalciuria thiazide
neuroimaging predictors of treatment failure in adult new-onset epilepsy

Conditions: Epilepsy; Seizures

Summary: epilepsy, defined as recurrent, unprovoked seizures, is a common condition, affecting 0.5-1% of the general population. people with uncontrolled epilepsy suffer poor health and increased mortality due to their condition. they frequently experience social stigma and are socioeconomically disadvantaged. it is therefore imperative to help them gain control of their seizures as quickly as possible. a wide range of antiepileptic drugs (aeds) has become available to treat people with epilepsy. however, despite maximal therapy, approximately 20-40% show pharmacoresistance (pr) and thus continue to have seizures. we do not understand why a significant proportion of people with epilepsy have pr. for any given patient presenting with a first unprovoked seizure, we are unable to predict pr at the time of presentation. at least 2 different aeds must be tried at maximum doses for a year before we can diagnose pr. at this point, surgical therapies become an increasingly urgent consideration. retrospective magnetic resonance imaging (mri) studies in the chronic stages of epilepsy have shown that patients with pr are more likely to have focal structural lesions in the brain, and in particular to have signs of damage to the hippocampi. for example, there are retrospective data suggesting that a decreased hippocampal n-acetylaspartate (naa)/creatine ratio (measured by magnetic resonance spectroscopy \[mrs\]) and hippocampal atrophy (determined by hippocampal volumetry) correlate with pr. however, it is not clear whether these findings reflect the underlying pathophysiology of pr, or simply reflect the effects of chronic seizures and chronic drug treatment on the brain. the first seizure clinic at the halifax infirmary represents a unique opportunity for prospective, longitudinal studies of patients who present with a first seizure or with newly diagnosed epilepsy. in these patients, advanced neuroimaging techniques at presentation might show changes that truly reflect the underlying pathophysiology of pr, rather than changes that develop as a consequence of prolonged seizures and drug treatment. neuroimaging follow-up might help us to understand the pathophysiologic changes that accompany the evolution of pr. ultimately, it is our hope to combine neuroimaging features and clinical features of patients with pr in a predictive model that would help us to predict pr at presentation.


Eligibility criteria:
inclusion criteria: * age 17 years * newly diagnosed epilepsy or history of first unprovoked, witnessed seizure exclusion criteria: * lack of consent provoked seizure due to obvious * acute lesion on ct (e.g. stroke, hemorrhage * provoked seizure due to obvious, chronic lesion on ct (e.g. vascular malformation, tumour) * progressive brain disease (e.g. neoplastic, infectious, demyelinating diseases) * history of epilepsy longer than 1 year at presentation to fsc * history of aed treatment for more than 4 weeks * contraindication to mri

Keywords: pharmacoresistance
safety study of anti-macrophage migration inhibitory factor (anti-mif) antibody in lupus nephritis

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to determine the safety and tolerability of anti-mif antibody in subjects with lupus nephritis.


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent obtained from the subject * males and females of age 18 years and older at the time of screening * established diagnosis of systemic lupus erythematosus (sle) according to the american college of rheumatology classification criteria * documented renal biopsy evidence of proliferative glomerulonephritis prior to screening * urine protein-to-creatinine ratio \> 0.5 (mg/mg) exclusion criteria: * any significant health problem other than lupus or lupus nephritis
utilization of microbiome as biomarkers and therapeutics in immuno-oncology

Conditions: Solid Carcinoma

Summary: this is an open label, single-center, non-randomized clinical trial on utilization of microbiome as biomarkers and therapeutics in immuno-oncology. this research consists of two parts: part 1: development of microbiome biomarkers for immuno-oncology part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor


Eligibility criteria:
part 1: development of microbiome biomarkers \ 1.patients with pathologically confirmed solid cancer who are being treated with immunotherapy or are going to receive immunotherapy 1. age ≥ 19 years old 2. eastern cooperative oncology group performance status 0-2 3. measurable or evaluable lesion(s) according to response evaluation criteria in solid tumors (recist) v1.1 \ 1. a history of other cancers requiring treatment within the recent 3 years (excepting treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, breast, or stomach) 2. a history of active primary immunodeficiency 3. active infection including tuberculosis or human immunodeficiency virus (hiv) 4. autoimmune disease (excepting type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disease not requiring systemic therapy (such as vitiligo, psoriasis or alopecia) 5. patients who are receiving immunosuppressive medications (excepting topical steroids, systemic steroid ≤10 mg/day prednisone or equivalents, or a brief course of steroids for prophylaxis (e.g., hypersensitivity reaction) -------------------------------------------------------------------------------------------- part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for solid cancers \ 1. patients who have partial or complete response to immunotherapy at the time of stool donation 2. no history of exposure to hiv or hepatitis virus within the previous 12 months 3. no history of international travel within previous 6 months to areas of high risk of travelers' diarrhea 4. no current communicable disease 5. no household members with active gastrointestinal infection 6. no history of inflammatory bowel disease 7. no recent intake of potential allergenic foods that are known to cause hypersensitivity in a recipient (such as peanut) \ 1. patients without contraindications for colonoscopy such as suspected bowel perforation, acute diverticulitis, or fulminant colitis 2. patients who have disease progression to immunotherapy as one of the following two patterns: 2-1) patients who have disease progression due to primary resistance to immunotherapy 2-2) patients who have disease progression following disease stabilization due to secondary resistance to immunotherapy

Keywords: immuno-oncology immunotherapy biomarker fecal microbiota transplantation (fmt) microbiome
trial to determine which of two surgical techniques works better to correct vaginal bulging

Conditions: Rectocele

Summary: women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at clarian health are eligible to enroll in this study. two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. one of the surgical methods uses an additional graft material and one surgical method does not. it is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.


Eligibility criteria:
inclusion criteria: * women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy exclusion criteria: * concomitant colo-rectal procedure * allergy to pork * any contraindication to laparoscopic sacrocolpopexy
role of montelukast in asthma and allergic rhinitis patients

Conditions: Asthma and Allergic Rhinitis

Summary: to determine the effect of montelukast in asthma and allergic rhinits patients

montelukast is a potent and selective blocker of the cyslt1 receptor. accordingly, a recent study has shown that montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. for treatment of asthma, montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. asthma and allergic rhinitis have been linked clinically for many years as "one airway one diseases". patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis

Eligibility criteria:
inclusion criteria: * age \>18 years * signed informed consent * clinical diagnosis of asthma and allergic rhinitis exclusion criteria: * previous adverse reaction to montelukast * history of hyper-eosinophilic disorder other than atopic disease * female subjects who are pregnant, breast-feeding * any significant and active pulmonary pathology other than asthma

Keywords: maap asthma allergic rhinits
patients with geographic atrophy and their patient journey in the united states (us)

Conditions: Geographic Atrophy

Summary: to quantify and describe patients with a geographic atrophy (ga) diagnosis in at least one eye, and the progression to neovascular age-related macular degeneration (including how many receive anti-vegf), or to ga (in the fellow eye only).


Eligibility criteria:
inclusion criteria: - all patients ≥50 years, with a ga diagnosis in at least one eye, included in the vestrum database identified during the study period (january 2015 to april 2023). exclusion criteria: - patients without the information of laterality will be excluded.
cerebral oximetry as an auxiliary diagnostic tool in the diagnosis of brain death

Conditions: Brain Death

Summary: aim: to investigate the efficacy of cerebral oximetry (co) as an auxiliary diagnostic tool in confirming brain death (bd). materials and methods: this observational and interventional study was performed on patients with suspected bd in emergency departments and intensive care units. co monitoring was performed for at least 6 h, and cerebral tissue oxygen saturation (sco2) was recorded. basal sco2 values (basal sco2), sco2 values after 6 h (end sco2), mean sco2 values during monitoring (mean sco2), and minimum (min sco2) and maximum (max sco2) sco2 values observed during monitoring were recorded for all patients. patients with diagnosis of bd confirmed by the organ transplantation and brain death committee were enrolled as the bd group and other patients as the non-bd group, and cerebral oxygen parameters were compared.

brain death (bd) means the irreversible loss of all brain and brain stem functions and physiopathologically the cessation of intracranial circulation. bd is a clinical diagnosis that can be made with various clinical tests. however, in order for bd to be definitely established, clinical tests performed initially need to be repeated after 24 h or to be confirmed by corroboratory tests. in addition, the obligation to confirm bd using corroboratory tests varies in current guidelines from country to country but has been eliminated except for certain specific circumstances. however, considering the adverse effects on patients awaiting donor and organ donations of the time lapse between initial and repeat tests in order to confirm bd, more rapid confirmation of definite bd is commonly made using corroboratory tests. this study was planned with the hypothesis that this non-invasive technique using nirs technology can be an auxiliary tool in the diagnosis of bd. this study was performed with patients with suspected bd in emergency departments and intensive care units and was intended to evaluate the effectiveness of cerebral oximetry as an auxiliary diagnostic tool in patients with suspected bd.

Eligibility criteria:
inclusion criteria: 1. all patients monitored and treated in the emergency department of intensive care units with a gcs score of 3 and evaluated as brain-dead at consultation with the organ transplantation brain death committee on suspicion of bd 2. aged over 18 years exclusion criteria: 1. cause of coma being undetermined 2. lack of confirmation of brain injury being diffuse and irreversible 3. central body temperature being lower than 32°c 4. presence of a picture of hypotensive shock 5. coma after drug effects and intoxications 6. presence of metabolic, electrolyte or acid-alkaline disorders